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PharmaCompass offers a list of Mycophenolate Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mycophenolate Sodium manufacturer or Mycophenolate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mycophenolate Sodium manufacturer or Mycophenolate Sodium supplier.
PharmaCompass also assists you with knowing the Mycophenolate Sodium API Price utilized in the formulation of products. Mycophenolate Sodium API Price is not always fixed or binding as the Mycophenolate Sodium Price is obtained through a variety of data sources. The Mycophenolate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mycophenolate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mycophenolate Sodium, including repackagers and relabelers. The FDA regulates Mycophenolate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mycophenolate Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Mycophenolate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mycophenolate Sodium supplier is an individual or a company that provides Mycophenolate Sodium active pharmaceutical ingredient (API) or Mycophenolate Sodium finished formulations upon request. The Mycophenolate Sodium suppliers may include Mycophenolate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Mycophenolate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mycophenolate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Mycophenolate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Mycophenolate Sodium DMFs exist exist since differing nations have different regulations, such as Mycophenolate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mycophenolate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Mycophenolate Sodium USDMF includes data on Mycophenolate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mycophenolate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mycophenolate Sodium suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Mycophenolate Sodium Drug Master File in Korea (Mycophenolate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mycophenolate Sodium. The MFDS reviews the Mycophenolate Sodium KDMF as part of the drug registration process and uses the information provided in the Mycophenolate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mycophenolate Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Mycophenolate Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mycophenolate Sodium suppliers with KDMF on PharmaCompass.
A Mycophenolate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Mycophenolate Sodium Certificate of Suitability (COS). The purpose of a Mycophenolate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mycophenolate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mycophenolate Sodium to their clients by showing that a Mycophenolate Sodium CEP has been issued for it. The manufacturer submits a Mycophenolate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mycophenolate Sodium CEP holder for the record. Additionally, the data presented in the Mycophenolate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mycophenolate Sodium DMF.
A Mycophenolate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mycophenolate Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Mycophenolate Sodium suppliers with CEP (COS) on PharmaCompass.
A Mycophenolate Sodium written confirmation (Mycophenolate Sodium WC) is an official document issued by a regulatory agency to a Mycophenolate Sodium manufacturer, verifying that the manufacturing facility of a Mycophenolate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mycophenolate Sodium APIs or Mycophenolate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Mycophenolate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Mycophenolate Sodium suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Mycophenolate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mycophenolate Sodium API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Mycophenolate Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Mycophenolate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mycophenolate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mycophenolate Sodium suppliers with NDC on PharmaCompass.
Mycophenolate Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Mycophenolate Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Mycophenolate Sodium GMP manufacturer or Mycophenolate Sodium GMP API supplier for your needs.
A Mycophenolate Sodium CoA (Certificate of Analysis) is a formal document that attests to Mycophenolate Sodium's compliance with Mycophenolate Sodium specifications and serves as a tool for batch-level quality control.
Mycophenolate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Mycophenolate Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Mycophenolate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Mycophenolate Sodium EP), Mycophenolate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mycophenolate Sodium USP).